and Human Services (HHS)
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Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National
Institute on Aging (NIA) (http://www.nia.nih.gov )
National Institute of Mental Health
(NIMH) (http://www.nimh.nih.gov)
Title: : Biomarkers for Older Controls at
Risk for Dementia (BIOCARD) Study Extension (U01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Catalog of Federal Domestic Assistance Number(s)
93.866, 93.242
Key Dates
Release
Date: March 20, 2008
Letters
of Intent Receipt Date: May
11, 2008
Application Receipt Date: June 11, 2008
Peer
Review Date: September/October,
2008
Council
Review Date: January 2009
Earliest Anticipated Start Date: April 1, 2009
Additional Information To Be
Available Date (Url Activation Date): Not
applicable
Expiration
Date: June 12, 2008
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2.
NIH Responsibilities
3.
Collaborative Responsibilities
4.
Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The purpose of this
announcement is to
solicit U01 cooperative agreement applications that will extend the clinical
and neuropsychological follow-up of individuals who have been enrolled in the
Biomarkers for Older Controls at Risk for Dementia (BIOCARD) Study.
Background
The BIOCARD Study is a longitudinal study that was initiated in 1995 in the National Institute of Mental Health (NIMH) Intramural Research Program that assessed the ability of clinical, neuropsychological, and neuropsychiatric evaluations, neuroimaging, and fluid biomarkers to understand and predict progression from normal cognition to mild cognitive impairment (MCI) and dementia, particularly Alzheimer’s disease (AD). It enrolled cognitively normal individuals who were first degree relatives of family members who had dementia. Average age at entry was 55 years, and these participants received cognitive testing every year, a full cognitive battery every two years, and a magnetic resonance imaging (MRI) scan and a lumbar puncture for collection of cerebral spinal fluid (CSF) every 2-4 years. As of 2005, some participants had been followed for up to 10 years. In 2005, the BIOCARD Study was suspended. In October, 2006 representatives of the National Institute on Aging (NIA) and NIMH met to review the BIOCARD study, and as the result of that meeting there was a decision to convene a group of experts with the charge to provide advice about whether this study was of sufficient scientific interest and importance that NIA/NIMH should consider extending the study to collect data on available participants who would consent to be followed. The meeting of experts was held by teleconference in April, 2007, and the recommendation of the group was that the BIOCARD Study was an extremely valuable study with a wealth of information already collected, that the participants were highly motivated individuals, and that the NIA/NIMH should consider extending the BIOCARD study to collect additional cognitive and dementia outcomes. However, they also indicated that information would have to be provided regarding the number of individuals who would potentially agree to further participation. In June, 2007 NIMH sent out letters to about 350 BIOCARD participants potentially available for follow-up to ask if they would be interested in continuing their participation in the study, and about 200 indicated that they would be interested. Based on the recommendations of the expert group and on the response to the survey of BIOCARD participants, in September, 2007 the National Advisory Council on Aging approved the development of this RFA to extend the clinical and neuropsychological evaluations of the BIOCARD participants who will consent to be followed. In addition, all of the previous clinical and neuropsychological data which have been collected, the biological samples which have been stored (plasma, CSF), and the MRI data from consenting participants will be provided to the successful grantee with the provision that a system will be set up to share these data and samples with the greater scientific community as well as the data and samples that will be collected during this extension period.
A listing of the publications which have utilized participants of the BIOCARD Study is provided at the end of this section to indicate the types of data analyses that have been done thus far.
Scope and Objective
The objective of this announcement is to solicit cooperative agreement applications that will provide for the medical, clinical, neuropsychological, and neuropsychiatric follow-up of individuals who were enrolled in the BIOCARD Study and to diagnose any participants who progress to mild cognitive impairment and/or dementia, particularly Alzheimer s disease (AD).
These participants have received up to 10 years of prior testing in these areas. The types of evaluations that have been done include the following: Medical evaluations included routine blood tests such as serum electrolytes, hepatic panel, complete blood count, thyroid function tests, lipid levels, hearing and vision tests, blood pressure, etc. Clinical evaluations included such tests as activities of daily living, Brief Psychiatric Rating Scale, and the Dementia Mood Assessment Scale. Neuropsychological and neuropsychiatric evaluations included an extensive battery of tests in various cognitive domains including the following: Mattis Dementia Rating Scale, National Adult Reading Test, Wechsler Memory Scale-Revised, Wechsler Adult Intelligence Scale-Revised, Boston Naming Task, Alzheimer’s Dementia Assessment Scale-Cognitive, Category and Letter Fluency, Purdue Peg Board, Rey Figure Copy, Street Map, Clock Drawing, 12 Work Buschke & Delay Recall and Recognition, Response Time Task, California Verbal Learning Task, Trails A & B, Stroop, Visual Attention Tasks.
Blood has been collected for genetic testing for Apolipoprotein E (APOE) alleles. MRIs have been done. Participants have also received lumbar punctures for collection of CSF.
For all of these measures, the history of repeated testing for individual subjects will be provided to the grantee.
The applicants should discuss the medical, clinical, neuropsychological, and neuropsychiatric evaluations that they propose to use and the follow up intervals (probably at least yearly) to assess progression to cognitive decline, MCI, and AD with the flexibility to evaluate individuals at shorter intervals if there is a change in their medical/cognitive status. The applicants should discuss what would trigger diagnostic evaluations for MCI and /or AD and how they will document the diagnostic decision making process for MCI and AD.
All of the previous data will be provided to the grantee as well as the freezers containing the biological samples. The grantee must indicate in the application a system for soliciting requests for access of these data and samples by the outside scientific community; how these requests will be evaluated and prioritized, such as by the use of an external resource allocation review committee; and how the data and/or samples will be provided/shipped to outside scientists. They also need to indicate how the samples will continue to be stored. This system for access to data and samples must be transparent and fair to all.
An important feature of this extension study is that the de-identified medical, clinical, neuropsychological, neuropsychiatric, genetic, and MRI data from the participants and data from analyses of the biological fluids will be made available in the public domain to all qualified scientific investigators. This includes both the previous data and samples as well as the data collected during this extension. The applicants should discuss how they would propose to set up this public database and how it would operate.
If the applicants propose any analyses of the extant biological samples, especially CSF, these should be done using methods consistent with those of the Alzheimer’s Disease Neuroimaging Initiative (ADNI). See the ADNI web site for further information, http://www.adni-info.org .
The investigators will be responsible for delineating protocols; setting up, coordinating, and monitoring recruitment and retention activities; organizing and monitoring data and sample collection, storage, and distribution; analyzing the longitudinal data, both the data that have been collected and the data to be collected in this extension study; and other administrative functions such as organizing Steering Committee meetings. A Steering Committee composed of the principal investigator, the co-investigators, and appropriate NIA staff will coordinate the work of this study. To advise the Steering Committee, applicants should also plan to recruit an external advisory committee, consisting of scientists from outside the institutions awarded funding for the study. External advisory committee members should not be recruited until the NIH review is complete. This committee will be used to evaluate progress, ensure that data monitoring procedures are sufficient and that quality data are being collected to the highest standards possible and any other activities for which outside expertise is required or desirable. The NIA project coordinator, who will also serve as the program administrator, will attend each meeting of this committee as an observer.
The applicant should consider whether including an autopsy component for confirmation of diagnosis or for other research purposes would be useful and advantageous.
Although all participants have been genotyped for APOE, the applicants should discuss the potential usefulness of collection a new blood sample for preparation of additional DNA or cell lines or storing of frozen lymphocytes for further genetic analyses.
Consent will need to be provided by participants for sharing of the previous data (medical/clinical/neuropsychological/neuropsychiatric , genetic, MRI) and samples (plasma and CSF) collected by the study, as well as for data and samples which will be collected in this extension study. The method for this should be discussed in the application, including layered consent for previous and new data and samples and for provision of these data and samples to outside academic and private sector scientists.
Because most of these participants are older individuals living in the greater Washington, DC area, travelling long distances would be an added burden. Therefore the grantee must be able to provide facilities to test participants at a site within approximately a 70 mile radius of Washington, DC.
BIOCARD publications
Cohen RM, Szczepanik J, McManus M, Mirza N, Putnam K, Levy J, Sunderland T. Hippocampal atrophy in the healthy is initially linear and independent of age. Neurobiol Aging. 2006 Oct;27(10):1385-94.
Cohen RM, Carson RE, Filbey F, Szczepanik J, Sunderland T. Age and APOE-epsilon4 genotype influence the effect of physostigmine infusion on the in-vivo distribution volume of the muscarinic-2-receptor dependent tracer[18F]FP-TZTP. Synapse. 2006 Jul;60(1):86-92.
Rosen VM, Sunderland T, Levy J, Harwell A, McGee L, Hammond C, Bhupali D, Putnam K, Bergeson J, Lefkowitz C. Apolipoprotein E and category fluency: evidence for reduced semantic access in healthy normal controls at risk for developing Alzheimer's disease.
Neuropsychologia. 2005;43(4):647-58.
Greenwood PM, Sunderland T, Putnam K, Levy J, Parasuraman R. Scaling of visuospatial attention undergoes differential longitudinal change as a function of APOE genotype prior to old age: results from the NIMH BIOCARD study. Neuropsychology. 2005 Nov;19(6):830-40.
Greenwood PM, Lambert C, Sunderland T, Parasuraman R. Effects of apolipoprotein E genotype on spatial attention, working memory, and their interaction in healthy, middle-aged adults: results From the National Institute of Mental Health's BIOCARD study. Neuropsychology. 2005 Mar;19(2):199-211.
Sunderland T, Mirza N, Putnam KT, Linker G, Bhupali D, Durham R, Soares H, Kimmel L, Friedman D, Bergeson J, Csako G, Levy JA, Bartko JJ, Cohen RM.
Cerebrospinal fluid beta-amyloid1-42 and tau in control subjects at risk for Alzheimer's disease: the effect of APOE epsilon4 allele. Biol Psychiatry. 2004 Nov 1;56(9):670-6.
Levy JA, Bergeson J, Putnam K, Rosen V, Cohen R, Lalonde F, Mirza N, Linker G, Sunderland T. Context-specific memory and apolipoprotein E (ApoE) epsilon 4: cognitive evidence from the NIMH prospective study of risk for Alzheimer's disease.
J Int Neuropsychol Soc. 2004 May;10(3):362-70.
Cohen RM, Podruchny TA, Bokde AL, Carson RE, Herscovitch P, Kiesewetter DO, Eckelman WC, Sunderland T. Higher in vivo muscarinic-2 receptor distribution volumes in aging subjects with an apolipoprotein E-epsilon4 allele. Synapse. 2003 Sep 1;49(3):150-6.
Cohen RM, Small C, Lalonde F, Friz J, Sunderland T. Effect of apolipoprotein E genotype on hippocampal volume loss in aging healthy women. Neurology. 2001 Dec 26;57(12):2223-8.
Greenwood PM, Sunderland T, Friz JL, Parasuraman R. Genetics and visual attention: selective deficits in healthy adult carriers of the epsilon 4 allele of the apolipoprotein E gene. Proc Natl Acad Sci U’s A. 2000 Oct 10;97(21):11661-6.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This
funding opportunity will use the U01award mechanism. The Project Director/Principal Investigator (PD/PI)
will be solely responsible for planning, directing, and executing the proposed
project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The
estimated amount of funds available to support one project
awarded as a result of this announcement is approximately $1.5 million dollars
in direct costs in FY2009. An applicant may request a project period not
to exceed five years and a budget for direct costs based on a comparable level
of funding for future years.
Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of the
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation; see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants are not permitted to submit a resubmission
application in response to this FOA.
Renewal applications are not permitted in response to this FOA.
Applicants may not submit more than one application.
Section IV. Application and Submission Information
1. Address to
Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and
number of this funding opportunity must be typed on lines 1 and 2 of the face
page of the application form and the YES box must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent
Receipt Date: May 11, 2008
Application Receipt Date: June 11, 2008
Peer Review Date: September/October, 2008
Council Review Date: January 2009
Earliest
Anticipated Start Date: April 1, 2009
3.A.1.
Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent
should be sent to:
Neil Buckholtz, Ph.D
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue
Gateway Building, Suite 350
Bethesda, MD 20892
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: buckholn@nia.nih.gov
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Ramesh
Vemuri, Ph.D
Scientific Review Office
National Institute on
Aging
7201 Wisconsin Avenue
Gateway Building, 2C218
Bethesda, MD 20892
Telephone: (301) 402-7700
FAX: (301) 402-0066
Email: vemuri@nia.nih.gov
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for responsiveness
by the reviewing Institute Incomplete and/or non-responsive applications will
not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants
Policy Statement.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or competing renewal award
if such costs: 1) are necessary to conduct the project, and 2) would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or competing renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
PHS398 Research Plan Component Sections
Not Applicable
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to
the FOA will be evaluated for scientific and technical merit by
an appropriate peer review group convened by NIA and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the results of this study help to understand the factors that affect disease progression from normal cognitive aging to MCI to AD?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Are the proposed plans and experience relating to subject
retention, staff training, data collection, monitoring, management, processing,
and reporting adequate? Is the approach to developing a cooperative
relationship among the study components adequate? Are the plans for exercising
appropriate leadership in matters of study design, data acquisition, data
management, and data distribution demonstrated?
Innovation: Is the
project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area? Are there novel ideas and methods
involving the prediction of disease progression?
Investigators: Are the
investigators appropriately trained and well suited to carry out this work? Is
the work proposed appropriate to the experience level of the principal
investigator and other researchers? Does the investigative team bring
complementary and integrated expertise to the project? Does the
application provide evidence of specific competence and relevant experience of
professional, technical, and administrative staff pertinent to the functions
involved in the extension study? Have the investigators and the staff
documented experience and capabilities evaluating the types of subjects in this
study?
Environment: Does the
scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support? Does the scientific environment in which the work will be
done contribute to the probability of success?
2.A.
Additional Review Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:
Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed (see the Research Plan section on Human
Subjects in the PHS 398 instructions).
Inclusion
of Women and Minorities in Research: The adequacy of plans to include subjects from both
genders, and all racial and ethnic groups (and subgroups), as appropriate for
the scientific goals of the research, will be assessed. Plans for the
recruitment and retention of subjects will also be evaluated (see the Research
Plan section on Human Subjects in the PHS 398 instructions).
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C.
Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
An important feature of this FOA is that the clinical, neuropsychological, neuropsychiatric, genetic, imaging, and biological data and samples from the prior study as well as the data from this extension study will be placed in the public domain and made available to all qualified investigators by methods and at time intervals to be determined by the Steering Committee. All of the previous data will be provided to the grantee as well as the freezers containing the biological samples. In addition, new data will be collected in this extension study. The applicant must indicate in the application a system for soliciting requests for access to these data and samples by the outside scientific community; how these requests will be evaluated, such as by the use of an external resource allocation review committee for the samples; and how the data and/or samples will be provided/shipped to outside scientists. They also need to indicate how the samples will continue to be stored. This system for access to data and samples must be transparent and fair to all.
3. Anticipated Announcement and Award
Dates
Not
Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative
and National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
2.A.
Cooperative Agreement Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when State and local Governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.
2.
A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for the overall management of the study and should agree to work cooperatively with the all components of the study and will have the primary responsibility for developing and implementing systems necessary for communications among the various study organizational components.
Awardees will retain custody of, and primary rights to, the data developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies, with the added stipulation that all data and samples shall be shared freely by methods and within time periods to be specified by the Steering Committee, as an important purpose of this study is the establishment of a public database.
The primary governing body of the study will be the Steering Committee, which will have responsibility for the final details of study design and policy decisions and will define the rules regarding access to data and samples.
2. A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The designated NIA Project Scientist will serve as a member of the Steering Committee and have substantial scientific/programmatic involvement during conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants. The awardee agrees to accept assistance from the designated NIA Project Scientist. This person will participate, through the Steering Committee, in the monitoring of issues relating to recruitment, follow-up, and adherence to protocols and will assist in the development and/or adjustment of study protocols. In addition to the NIA Project Scientist, there will also be NIA and NIMH Program Officials who will be responsible for the normal programmatic stewardship on this award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
The Steering Committee,
comprised of the PI of the cooperative agreement, the co-investigators, and the
NIA Project Scientist will have primary responsibility for finalizing standard
definitions, procedures, and measures common for all the protocols. The
steering committee will meet every six months, or as dictated by the needs of
the study. Each full member of the Steering Committee will have one vote, and
all major scientific decisions will be determined by majority vote of the
Steering Committee. Awardee members of the Steering Committee will be required
to accept and implement policies approved by the Steering Committee.
Subcommittees may be appointed by the Steering Committee, as needed, for the
design of protocols and manuals of operations and in ongoing functions of the
study such as preparation of publications.
To oversee the allocation and distribution of biological specimens, the Steering Committee will nominate members for the Resource Allocation Review Committee (RARC). This group will review applications for use of the biological specimens. The format of the application and criteria for the use of repository biological specimens will be developed by the RARC with advice and approval from the Steering Committee and made available to all potential users. The RARC will be made up of individuals not directly involved in the study and without conflicts of interest. Membership on this committee will rotate periodically according to a procedure developed by the RARC. Final approval of members of the RARC and final approval for disposition of samples to investigators following RARC review will be made by NIA staff.
2.A.4. Arbitration Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage
your inquiries concerning this funding opportunity and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
1. Scientific/Research Contacts:
Neil Buckholtz, Ph.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-9350
FAX:
(301) 496-1494
Email: buckholn@nia.nih.gov
Jovier
Evans, Ph.D.
National
Institute of Mental Health
NSC/7218
6001
Executive Boulevard
Rockville, MD 20892-9634
Telephone:
(301) 443-1369
FAX:
(301) 443-1424
Email:
jevans1@mail.nih.gov
2. Peer Review Contacts:
Ramesh Vemuri, Ph.D
Scientific Review Office
National Institute on Aging
Gateway Building, Suite 2C218
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 402-7700
FAX: (301) 402-0066
Email: vemuri@nia.nih.gov
3. Financial or Grants Management Contacts:
Janis Peterson
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: petersja@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of
PHS support for activities involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human
Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and
Safety Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide public
access to research data through the Freedom of Information Act (FOIA) under
some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education
on the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research. Applications that do
not provide this information will be returned without review.
NIH Public Access Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under the
policy, and was authored or co-authored by the investigator or arose from the
investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy
Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is
described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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